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NCT00224835 · ClinicalTrials.gov registry record · NA
Mindfulness-Based Stress Reduction and Myocardial Ischemia
A NA study, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT00224835 is a NA study that has completed, run by University of Florida. The registered enrollment target is 150 participants.
The verdict
NCT00224835, a NA study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
Study Summary
The principal objective of the study is to evaluate the effectiveness of a widely used complementary medicine intervention, mindfulness-based stress reduction (MBSR), in which mindfulness meditation and yoga are the principal components in the treatment of a chronic, often fatal illness that affects tens of millions of Americans. The investigators propose to conduct a single center randomized controlled trial in which 150 patients will be assigned to either a mindfulness meditation condition, a disease education control condition, or a stress-monitoring usual care control condition. They will test the following specific hypotheses: 1. In comparison to either of the control conditions, significantly more coronary artery disease (CAD) patients in the mindfulness meditation condition will demonstrate reductions in mental stress-induced ischemia. 2. The ratio of low-to-high frequency of spectral power in heart rate variability during ambulatory monitoring will be significantly decreased following the participation in a stress reduction program compared with those in a disease education or usual care condition. 3. Patients in the mindfulness meditation condition will report greater improvement in quality of life (i.e., reductions in general psychological symptomology, anger, anxiety, depression, and daily stress, along with increases in optimism and stress coping efficacy) than patients in either of the control conditions. 4. Day-to-day variability in self-reported mental stress will be inversely related to day-to-day stress coping efficacy in the entire sample and time spent in mindfulness practice in the active treatment condition, and these relationships will be maintained over a 3-month follow-up. 5. Patients with CAD and mental stress ischemia who show an \*abnormal peripheral artery response during baseline studies will show a significant improvement after mindfulness intervention. * Abnormal responses will be defined as peripheral arterial tonometry (PAT) tra
Interventions
- BEHAVIORAL Mindfulness Based Stress Reduction Class
- BEHAVIORAL Cardiac Education Class
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2003-05 |
| Est. Completion | 2008-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00224835
The ClinicalTrials.gov registry entry for NCT00224835 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mindfulness Based Stress Reduction Class is the first listed.
NCT00224835 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00224835 about?
NCT00224835 is a clinical study titled "Mindfulness-Based Stress Reduction and Myocardial Ischemia". The principal objective of the study is to evaluate the effectiveness of a widely used complementary medicine intervention, mindfulness-based stress reduction (MBSR), in which mindfulness meditation and yoga are the principal components in the treatment of a chronic, often fatal illness that affects...
What is the current status of trial NCT00224835?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2003-05. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00224835?
The interventions under investigation include: Mindfulness Based Stress Reduction Class (BEHAVIORAL), Cardiac Education Class (BEHAVIORAL).
Who is sponsoring clinical trial NCT00224835?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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